CLINICAL TRIALS PROFILE FOR LIFILEUCEL

All Clinical Trials for lifileucel

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03645928 ↗	Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors	Recruiting	Iovance Biotherapeutics, Inc.	Phase 2	2019-05-07	A prospective, open-label, multi-cohort, non-randomized, multicenter Phase 2 study evaluating adoptive cell therapy (ACT) with TIL LN-144 (Lifileucel)/LN-145 in combination with checkpoint inhibitors or TIL LN-144 (Lifileucel)/LN-145/LN-145-S1 as a single agent therapy.
NCT05176470 ↗	Lifileucel and Pembrolizumab for the Treatment of Locally Advanced Stage IIIB-D Melanoma	Not yet recruiting	Iovance Biotherapeutics, Inc.	Phase 1/Phase 2	2022-02-01	This phase I/II trial tests the safety and side effects of lifileucel and pembrolizumab in treating patients with stage IIIB-D melanoma that has spread to nearby tissue or lymph nodes (locally advanced). Biological therapies, such as lifileucel, use substances made from living organisms that may attack specific tumor cells and stop them from growing or kill them. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving lifileucel and pembrolizumab may make the tumor smaller.
NCT05176470 ↗	Lifileucel and Pembrolizumab for the Treatment of Locally Advanced Stage IIIB-D Melanoma	Not yet recruiting	Richard Wu	Phase 1/Phase 2	2022-02-01	This phase I/II trial tests the safety and side effects of lifileucel and pembrolizumab in treating patients with stage IIIB-D melanoma that has spread to nearby tissue or lymph nodes (locally advanced). Biological therapies, such as lifileucel, use substances made from living organisms that may attack specific tumor cells and stop them from growing or kill them. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving lifileucel and pembrolizumab may make the tumor smaller.
NCT06151847 ↗	Lifileucel With Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion and Interleukin-2 for the Treatment of Patients With Unresectable or Metastatic Melanoma	Recruiting	Iovance Biotherapeutics, Inc.	Phase 2	2023-12-21	This phase II trial tests how well lifileucel, with reduce dose fludarabine and cyclophosphamide for lymphodepletion and interleukin-2, work for treating patients with melanoma that cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic).Lifileucel is made up of specialized immune cells called lymphocytes or T cells that are taken from a patient's tumor, grown in a manufacturing facility and infused back into the preconditioned patient to attack the tumor. Giving Lifileucel with a reduced dose of fludarabine and cyclophosphamide for lymphodepletion and interleukin -2 is being studied in patients with unresectable or metastatic melanoma.
NCT06151847 ↗	Lifileucel With Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion and Interleukin-2 for the Treatment of Patients With Unresectable or Metastatic Melanoma	Recruiting	National Cancer Institute (NCI)	Phase 2	2023-12-21	This phase II trial tests how well lifileucel, with reduce dose fludarabine and cyclophosphamide for lymphodepletion and interleukin-2, work for treating patients with melanoma that cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic).Lifileucel is made up of specialized immune cells called lymphocytes or T cells that are taken from a patient's tumor, grown in a manufacturing facility and infused back into the preconditioned patient to attack the tumor. Giving Lifileucel with a reduced dose of fludarabine and cyclophosphamide for lymphodepletion and interleukin -2 is being studied in patients with unresectable or metastatic melanoma.
NCT06151847 ↗	Lifileucel With Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion and Interleukin-2 for the Treatment of Patients With Unresectable or Metastatic Melanoma	Recruiting	University of Kansas Medical Center	Phase 2	2023-12-21	This phase II trial tests how well lifileucel, with reduce dose fludarabine and cyclophosphamide for lymphodepletion and interleukin-2, work for treating patients with melanoma that cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic).Lifileucel is made up of specialized immune cells called lymphocytes or T cells that are taken from a patient's tumor, grown in a manufacturing facility and infused back into the preconditioned patient to attack the tumor. Giving Lifileucel with a reduced dose of fludarabine and cyclophosphamide for lymphodepletion and interleukin -2 is being studied in patients with unresectable or metastatic melanoma.

Clinical Trial Conditions for lifileucel

Condition Name

Condition Name for lifileucel
Intervention	Trials
Metastatic Melanoma	2
Pathologic Stage IIIC Cutaneous Melanoma AJCC v8	2
Locally Advanced Melanoma	1
Non-small Cell Lung Cancer	1

Condition MeSH

Condition MeSH for lifileucel
Intervention	Trials
Skin Neoplasms	2
Melanoma	2
Squamous Cell Carcinoma of Head and Neck	1
Head and Neck Neoplasms	1

Clinical Trial Locations for lifileucel

Trials by Country

Trials by Country for lifileucel
Location	Trials
United States	17
Germany	3
Spain	2
United Kingdom	2
Greece	1

Trials by US State

Trials by US State for lifileucel
Location	Trials
Ohio	2
Kansas	1
Wisconsin	1
Washington	1
Utah	1

Clinical Trial Progress for lifileucel

Clinical Trial Phase

Clinical Trial Phase for lifileucel
Clinical Trial Phase	Trials
Phase 2	2
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for lifileucel
Clinical Trial Phase	Trials
Recruiting	2
Not yet recruiting	1

Clinical Trial Sponsors for lifileucel

Sponsor Name

Sponsor Name for lifileucel
Sponsor	Trials
Iovance Biotherapeutics, Inc.	3
Richard Wu	1
National Cancer Institute (NCI)	1

Sponsor Type

Sponsor Type for lifileucel
Sponsor	Trials
Industry	3
Other	2
NIH	1

Lifileucel: A Groundbreaking TIL Therapy in Clinical Trials and Market Projections

Introduction to Lifileucel

Lifileucel, developed by Iovance Biotherapeutics, is a pioneering Tumor-Infiltrating Lymphocyte (TIL) therapy that has recently garnered significant attention in the medical and pharmaceutical industries. This therapy represents a major advancement in the treatment of various cancers, particularly advanced melanoma.

Clinical Trials and Approval

FDA Approval for Advanced Melanoma

On February 16, 2024, the FDA granted accelerated approval to lifileucel for the treatment of adult patients with unresectable or metastatic melanoma who have been previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor[2][4].

Clinical Data and Outcomes

The approval was based on positive clinical data from the C-144-01 clinical trial, which showed that almost 50% of patients treated with lifileucel were alive four years after treatment. The median duration of response had not been reached at the four-year follow-up, indicating the potential for long-term responses[4].

Ongoing and Planned Trials

In addition to its approval for melanoma, lifileucel is being evaluated in several ongoing clinical trials. These include trials for lung cancer and combination therapies with immune checkpoint inhibitors for the first-line treatment of melanoma. A Phase 2 trial in advanced endometrial cancer is also set to initiate in the second quarter of 2024[2][4].

Global Regulatory Submissions

Iovance Biotherapeutics has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for lifileucel, marking the first step in its global expansion strategy. Additional submissions are planned for Canada, the United Kingdom, and Australia in 2024 and 2025[1].

Market Analysis and Projections

Market Size and Growth

The global TIL therapy market is expected to experience rapid growth, driven largely by the success of lifileucel. The market size is projected to grow from USD 0.087 billion in 2023 to USD 5 billion by 2035, representing a Compound Annual Growth Rate (CAGR) of 40%[3].

Target Indications

Lifileucel is anticipated to be a key driver in this market growth, particularly in the treatment of melanoma and head and neck carcinoma. The drug's potential in addressing significant unmet needs in these areas is a major factor in its market projection[3].

Revenue Forecasts

According to GlobalData, the revenue for lifileucel in the US is expected to reach an annual total of $584 million by 2036. This forecast is based on the drug's phase transition success rate, remaining R&D costs, and the likelihood of approval and sales-related costs[5].

Global Expansion and Market Impact

Addressing Unmet Needs

The global expansion of lifileucel is aimed at addressing the significant unmet need for effective treatments in advanced melanoma. More than 20,000 people die from advanced melanoma annually in the US, EU, UK, Canada, and Australia, making this therapy a critical addition to the treatment landscape[1].

Regulatory Feedback and Approval Process

The MAA submission for lifileucel to the EMA is expected to be validated in the third quarter of 2024, with the Committee for Medicinal Products for Human Use (CHMP) issuing a scientific opinion for the European Commission to adopt in 2025. Positive regulatory feedback from the FDA and other regulatory bodies has been instrumental in advancing lifileucel's global approval process[1][2].

Enhancing TIL Therapy

Genetic Modifications and Combination Therapies

Researchers are working to enhance the efficacy of TIL therapy through genetic modifications, such as inserting stem-like markers or tumor antigen-specific T-cell receptors. Efforts are also underway to combine TIL therapy with vaccines, improve selection and growth conditions, and identify more tumor antigens[4].

Future Directions

As reflected by Dr. Steven Rosenberg's work and insights, the next 30 years of TIL therapy research are expected to be transformative. Innovations in high-throughput sequencing technologies and the integration of TILs with other immunotherapies are likely to further expand the clinical applications of lifileucel and other TIL therapies[4].

Key Takeaways

• FDA Approval: Lifileucel received FDA approval for advanced melanoma in February 2024.
• Global Submissions: Marketing authorization applications have been submitted to the EMA, with plans for submissions in Canada, the UK, and Australia.
• Clinical Trials: Ongoing trials include evaluations for lung cancer and combination therapies with immune checkpoint inhibitors.
• Market Growth: The global TIL therapy market is projected to grow significantly, driven by lifileucel's success.
• Revenue Forecasts: Lifileucel's revenue in the US is expected to reach $584 million annually by 2036.
• Unmet Needs: The therapy addresses a significant unmet need for effective treatments in advanced melanoma.

FAQs

What is lifileucel and how does it work?

Lifileucel is a Tumor-Infiltrating Lymphocyte (TIL) therapy that involves extracting T cells from a patient's tumor, expanding them in the lab, and reinfusing them into the patient to fight cancer.

What is the current status of lifileucel's regulatory approvals?

Lifileucel has received FDA approval for the treatment of advanced melanoma. It has also been submitted for marketing authorization to the EMA and is planned for submission in Canada, the UK, and Australia.

What are the key clinical trials currently underway for lifileucel?

Ongoing trials include evaluations for lung cancer, combination therapies with immune checkpoint inhibitors, and a Phase 2 trial in advanced endometrial cancer.

How is the market for TIL therapies expected to grow?

The global TIL therapy market is projected to grow from USD 0.087 billion in 2023 to USD 5 billion by 2035, with a CAGR of 40%.

What are the revenue forecasts for lifileucel?

According to GlobalData, lifileucel's revenue in the US is expected to reach an annual total of $584 million by 2036.

How does lifileucel address unmet needs in cancer treatment?

Lifileucel addresses the significant unmet need for effective treatments in advanced melanoma, a condition that results in over 20,000 deaths annually in several major regions.

Sources

1. Iovance Biotherapeutics Submits Marketing Authorization Application to European Medicines Agency for Lifileucel in Advanced Melanoma. Biospace.
2. Iovance Biotherapeutics Reports First Quarter 2024 Financial Results. Iovance Biotherapeutics.
3. TIL Therapy Market Size, Share & Growth Forecast [2035]. Roots Analysis.
4. TIL Therapy: A New Melanoma Treatment 30 Years in the Making. American Association for Cancer Research.
5. What is the current valuation of Iovance Biotherapeutics's Lifileucel?. Pharmaceutical Technology.

Last updated: 2025-01-05